Thermo Fisher Scientific Quality Systems & Compliance Supervisor in Manati, Puerto Rico
The incumbent is faced with the challenge of coordinating the daily activities of the compliance documentation areas and be able to make decisions on issues in a timely manner.
The incumbent is faced with communicating with multiple departments and clients to coordinate site priorities and resolve multiple issues on a daily basis.
Communicating problems/delays to manufacturing operations, laboratories, Purchasing, Materials, Clients and regulatory agencies and QA.
Manage client and regulatory/clients.
Daily review and approval of documents such as procedures, specifications, Methods, APR, Change Control, protocols, reports, client/regulatory request, among others.
Oversees the QS personnel functions to ensure procedures are followed. Assure personnel are trained.
Needs a good understanding of procedures and regulations.
The incumbent is faced with the challenge of hosting Regulatory or Client Audits.
The incumbent is faced to support traveling around Puerto Rico, USA or any international territory to audit Thermofisher suppliers.
Revision/approval the Annual Product Review documents to ensure timely completion to clients.
Evaluate, challenge, and implement quality improvements to processes across PDS, Commercial and Quality operations.
Ensure change controls are completed in compliance with applicable standards.
The incumbent is faced with the constant communication with multiple clients to provide regulatory requirements Requests.
Ensure stand-alone CAPA and Corrective Actions request (CARF’s) are completed in compliance with applicable standards.
QA approval authority for protocols, reports, deviation reports (DR's), change controls.
Supervision responsibilities, such as: hire and fire; direct report career development and consequence management.
Communicate with FDA for licensing and submission, inspection and sampling purposes, as well receive federal agency.
QA approval authority prepare plant certifications
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.